Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Spike rates per hour (epilepsy marker)
研究概览
简要总结
Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.
详细描述
The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.
The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •At least 2 seizures per week based on clinical notes
- •Patients where medications will stay stable over the study period
- •40% of both spikes and spindles are identifiable on the dreem headband based on the screening night
排除标准
- •Cognitive impairment
- •Psychiatric comorbidities which may influence sleep
- •No bedpartner/caregiver to observe seizures
- •Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study
- •Apnea-hypopnea index of > 10/h
研究组 & 干预措施
Dreem headband
Participants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries.
干预措施: Dreem headband (Device)
结局指标
主要结局
Spike rates per hour (epilepsy marker)
时间窗: 21 days
Spikes will be detected by the Dreem headband
Total sleep time (sleep macrostructure)
时间窗: 21 days
Total sleep time as measured by the Dreem headband
Seizure frequency per night (epilepsy marker)
时间窗: 21 days
Seizures will be detected by the Dreem headband
次要结局
- Sleep latency (sleep macrostructure)(21 days)
- Sleep efficiency (sleep macrostructure)(21 days)
- Sleep stage distribution (sleep macrostructure)(21 days)
- Sleep spindle events (sleep microstructure)(21 days)
- Sleep slow wave events (sleep microstructure)(21 days)
- Performance the SERI model, as measured by the area under the receiver operating characteristic curve(Up to 2 years after study commencement)
- Wake after sleep onset (sleep macrostructure)(21 days)
- Specificity of the SERI model(Up to 2 years after study commencement)
- Performance the SERI model, as measured by F1-score(Up to 2 years after study commencement)
- Sensitivity of the SERI model(Up to 2 years after study commencement)